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Loading Dose or Standard Dose of Intravenous Ibandronate in Treating Patients With Lung Cancer and Skeletal Metastasis

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ClinicalTrials.gov Identifier: NCT00492843
Recruitment Status : Terminated (It is too difficult to recruit suitable patients.)
First Posted : June 27, 2007
Last Update Posted : February 17, 2016
Sponsor:
Information provided by (Responsible Party):
Yi-Long Wu, Chinese Society of Lung Cancer

Tracking Information
First Submitted Date  ICMJE June 25, 2007
First Posted Date  ICMJE June 27, 2007
Last Update Posted Date February 17, 2016
Study Start Date  ICMJE July 2007
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2007)
bone pain response (≥25% decrease in mean pain score with a maximum of 15% increase in mean analgesic consumption) [ Time Frame: 1 month ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00492843 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2007)
Efficacy: ECOG Performance status, Analgesic consumption, bone marker Safety: AE, laboratory parameters [ Time Frame: 1 month ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Loading Dose or Standard Dose of Intravenous Ibandronate in Treating Patients With Lung Cancer and Skeletal Metastasis
Official Title  ICMJE A Randomized Study to Evaluate the Safety and Efficacy of Loading Dose of Bondronat Versus Standard Dose of Bondronat in Patients With Lung Cancer and Skeletal Metastasis Experiencing Moderate to Severe Pain
Brief Summary The objective of this trial is to assess the efficacy and safety of loading doses versus standard dose of intravenous Bondronat in reducing pain in patients with lung cancer and bone metastatic disease.
Detailed Description Patients with lung cancer and bone metastatic disease may experience moderate or severe bone pain. Some researches have reported that loading doses Bondronat (6mg Bondronat on three consecutive days) had great efficacy in reducing pain in patients with malignant bone disease without unacceptable toxicities. So,we designed this clinical trial to compare the efficacy and safety profiles between loading doses Bondronat and standard dose Bondronat.Enrolled patients will receive an intravenous infusion of either 6mg Bondronat on three consecutive days or 6mg Bondronat on one day. The targeted sample size is 120 individuals. Primary outcome measures will be bone pain response ( ≥ 25% decrease in mean pain score with a maximum of 15% increase in mean analgesic consumption). Secondary outcome measures will be efficacy including ECOG Performance status, analgesic consumption, bone markers, and safety profiles including AE and laboratory parameters.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lung Cancer
Intervention  ICMJE Drug: Ibandronate (Bondronat)
Intravenous infusion of either 6mg Bondronat on three consecutive days or 6mg Bondronat on one day.
Other Name: no other names
Study Arms  ICMJE
  • Experimental: A
    Intravenous infusion of either 6mg Bondronat on three consecutive days
    Intervention: Drug: Ibandronate (Bondronat)
  • Active Comparator: B
    Intravenous infusion of 6mg Bondronat on one day
    Intervention: Drug: Ibandronate (Bondronat)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 9, 2008)
20
Original Estimated Enrollment  ICMJE
 (submitted: June 26, 2007)
120
Actual Study Completion Date  ICMJE July 2008
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Written informed consent
  • Age ≥ 18 years
  • Histological or cytological evidence of lung cancer
  • Presence of bone metastases documented on bone X-ray, bone ECT, CT scan or MRI scan
  • Mean pain score ≥ 4 during 3-day baseline period on the WORSE pain scale of the VAS
  • Patients must be on a stable dose of analgesics over the 3-day baseline period (maximum 15% variation is allowed)
  • ECOG Performance status of 0-3 (patients with PS of 3 must have their score based on bone pain, not underlying neoplastic disease)
  • Adequate renal function: creatinine clearance ≥ 50 ml/min (cockroft formula) and serum creatinine ≤ 2.0mg/dl (168 µmol/L); ALT or AST within 2 times the upper limit of the normal range

Exclusion Criteria:

  • Patients with an uncontrolled infection
  • Hypocalcemia
  • Patients who have received a bisphosphonate within 3 weeks of the start of the Baseline period or who are currently receiving another bisphosphonate
  • Patients with known hypersensitivity to any of the components of ibandronic acid
  • Patients who are pregnant or lactating
  • Radiotherapy to bone within the 28 days prior inclusion or during the trial duration
  • Patient who are currently treated with any other investigational therapy or have received it within 30 days of the first schedule day of dosing
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00492843
Other Study ID Numbers  ICMJE CSLC0701
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yi-Long Wu, Chinese Society of Lung Cancer
Study Sponsor  ICMJE Chinese Society of Lung Cancer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yilong Wu, MD Guangdong Provincial People's Hospital
PRS Account Chinese Society of Lung Cancer
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP